DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 14 August 2026 is acknowledged.
Upon reconsideration, the species election between films containing a biaxially oriented polyamide layer and those containing a biaxially oriented polyester layer is withdrawn.
Claim 18 (but not claim 20) is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 14 August 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 16 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 16 is rendered indefinite because the claim does not specify how the percentages are determined (e.g., mass, volume, etc.).
Claim Interpretation
For the purpose of examination, the percentages in claim 16 are presumed to be on the basis of mass.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirose (US 2020/0001579).
Hirose is directed to a laminate used to package an article (paragraph 0002). The article to be packaged may be medicine (paragraph 0108). In one embodiment the laminate comprises, in order: paper, an interposed adhesive, biaxially oriented polyethylene terephthalate, a second adhesive layer, an aluminum barrier layer, a first adhesive layer, a first sealant layer, and a second sealant layer (paragraph 0110, embodiment 9).
Claim Rejections - 35 USC § 102 / 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 14, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hirose (US 2020/0001579).
Hirose is directed to a laminate used to package an article (paragraph 0002). The article to be packaged may be medicine (paragraph 0108). The laminate comprises, in order, a base material layer, an adhesive layer, a barrier layer, an adhesive layer, a first sealant layer, and a second sealant layer (Figure 1 and paragraph 0018). The base material layer may be a combination of a paper and resin film (paragraph 0019), such as a paper and resin layer with an adhesive layer interposed between them wherein the paper layer is positioned towards the outside of the laminate and the resin layer is positioned towards the barrier layer (paragraphs 0110 - embodiment 9). The resin films may be biaxially oriented polyester or biaxially oriented polyamide having a preferred thickness of 6 to 30 mm (paragraph 0028). The adhesive layers may be solvent-type adhesives, aqueous adhesives, or adhesives that do not employ a solvent (i.e., reactive adhesive or hot-melt adhesive) (paragraphs 0023 and 0036). The barrier layer may be an aluminum foil having a thickness of 5 to 15 mm (paragraph 0026). The thickness of the adhesive layers is 0.1 to 1.0 mm (paragraph 0042). The first sealant layer constituting the outermost surface of the laminate is made of a cyclic polyolefin resin, such as a cyclic olefin copolymer (paragraphs 0043-0045). The first sealant layer suitably has a thickness of 30 mm (paragraph 0120).
While Hirose does not exemplify an embodiment wherein the base material layer is a layer of paper adhered to a layer of biaxially oriented polyamide, there is an explicit teaching that the base material layer may be a combination of paper and a resin film (paragraph 0019), with paper adhered to biaxially oriented polyethylene terephthalate specifically recited as a suitable base material layer (paragraph 0110 - embodiment 9). Moreover, Hirose explicitly teaches three resin films, biaxially oriented polyethylene terephthalate, biaxially oriented polyamide, and biaxially oriented polypropylene (paragraph 0028). As such, one of ordinary skill in the art would immediately envisage a base material layer formed from paper adhered to biaxially oriented polyamide. Alternatively, it would have been obvious to employ paper adhered to biaxially oriented polyamide as the base material layer since (i) Hirose explicitly teaches that paper adhered to biaxially oriented polyethylene terephthalate as a base material layer and (ii) Hirose shows that biaxially oriented polyethylene terephthalate and biaxially oriented polyamide are known in the art as functionally equivalent resin films for the base material layer of the laminate.
Regarding claim 3, the manner in which the biaxially oriented polyamide layer is formed represents a product-by-process type limitation. When the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claim in a product-by-process claim, the burden is on the applicant to present evidence from which the examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. In re Brown, 459 F. 2d 531, 173 USPQ 685 (CCPA 1972); In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). This burden is NOT discharged solely because the product was derived from a process not known to the prior art. In re Fessman, 489 F. 2d 742, 180 USPQ 324 (CCPA 1974). Furthermore, the determination of patentability for a product-by-process claim is based on the product itself and not on the method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) and MPEP § 2113. In this case, one of ordinary skill in the art would expect biaxially oriented polyamide layers to have the same properties regardless of the manner in which they are made since the resulting material is a polyamide that has been biaxially oriented.
Regarding claim 14, while Hirose is silent regarding the coating weight of the adhesive layers, there is an explicit teaching that the adhesive layers are applied at a thickness of 0.1 to 1 mm (paragraph 0042) - a thickness that would be expected to satisfy the limitations of claim 14. In the event that adhesive layers of 0.1 to 1 mm do not inherently satisfy the limitations of claim 14 and in the absence of a showing of criticality or unexpected results, it would have required no more than routine experimentation and ordinary skill to determine a suitable coating weight adhesive layer. Since the adhesive layer of Hirose is employed in the same manner and for the same purpose as the adhesive layers of claim 14 (i.e., a laminating adhesive of a packaging laminate), one of ordinary skill in the art would expect routine experimentation to result in adhesive layers satisfying the limitations of claim 14.
Regarding claim 17, Hirose teaches that the laminate may be used to package medicine (paragraph 0108). While Hirose does not recite specific drug to be packaged, the claims are directed to a film and not a packaged drug. As such, the specific drug to be packaged represents an intended use of the laminate. It has been held that a recitation with respect to the manner in which a claimed product is intended to be employed does not differentiate the claimed product from a prior art product satisfying the claimed structural limitations. See MPEP 2114.
Claim Rejections - 35 USC § 103
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hirose (US 2020/0001579).
Hirose teaches or suggests all the limitations of claim 7, as outlined above, except for illustrating an embodiment where the sealant layer is a monolayer. Furthermore, Hirose teaches or suggests all the limitations of claim 13, as outlined above, except the reference is silent regarding the thickness of the paper in units of grams per square meter.
Regarding claim 7, Hirose teaches that the second sealant layer is optional (embodiment 1 of paragraph 0110 teaches that one main surface of the first sealant layer is the outermost surface of the laminate while the other surface of the first sealant layer may be in contact with the first adhesive layer rather than a second sealant layer).
It would have been obvious to one of ordinary skill in the art to construct the sealing layer as a monolayer since the courts have held that the selection of a known material (in this case, a single sealant layer) based on its suitability for its intended use (in this case, the sealant layer of a packaging laminate) supported a prima facie obviousness determination (ee MPEP 2144.07) and Hirose teaches that the sealant layer can be a single layer.
Regarding claim 13, in the absence of a showing of criticality or unexpected results, it would have required no more than routine experimentation and ordinary skill to determine a suitable thickness for the paper base material of Hirose. Moreover, since the paper base material of Hirose is employed in the same manner and for the same purpose as the paper layer of claim 13 (i.e., a base layer of a packaging laminate), one of ordinary skill in the art would expect routine experimentation to result in a paper layer satisfying the limitations of claim 13.
Claims 8-12, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hirose (US 2020/0001579) in view of Okumura (JP 2017-013485).
Hirose teaches or suggests all the limitations of claims 8-12, 15, and 16, as outlined above, except for a sealant layer comprising three or four coextruded layers wherein the outermost layer comprises less than 90% cyclic olefin copolymer and greater than 10% polyethylene and additives and the other layers are polyethylene and/or cyclic olefin copolymer.
Okumura is directed to a packaging material comprising a low adsorption sealant film (paragraph 0001). When the material is used to package pharmaceutical/medicinal products, the sealant absorbs less product resulting in decreased costs (paragraphs 0002 and 0006). The sealant film comprises five layers: an outer layer, a first polyethylene layer, a second polyethylene layer, a first low-adsorption resin layer, and a second low-adsorption resin layer forming the layer in contact with the contents of the packaging (paragraph 0007). The outer and first polyethylene layers are made of linear low density polyethylene or low density polyethylene; the second polyethylene layer is made from linear low density polyethylene, the first low-adsorption resin layer is made from cyclic olefin copolymer and low density polyethylene, and the second low-adsorption resin layer (i.e., the product contact layer) is made from 15-65 mass% cyclic olefin copolymer, 30 to 80 mass% linear low density polyethylene, and 3 to 10 mass% low density polyethylene (paragraph 0008).
It would have been obvious to one of ordinary skill in the art to use the sealant film of Okumura as the sealant of Hirose to reduce costs by minimizing the adsorption of packaged product.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of copending Application No. 18/643,543 (reference application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the inventions of instant claim 20 represents a genus of which the invention described by claims 1 and 11 of copending Application No. 18/643,543 are species since sealing layer claimed in copending Application No. 18/643,543 is required to be a polyamide sealing layer while that of the instant claim is not limited to any particular material. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 13, 14, 17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-15 of copending Application No. 18/643,543 in view of Hirose (US 2020/0001579).
Claims 1 and 10-15 of copending Application No. 18/643,543 is directed to a drug resistant laminate reciting all the limitations of claims 1-6, 13, 14, 17, and 19 except for the use of a paper layer adhered to a biaxially oriented polyamide layer as the support layer.
Hirose is directed to a laminate used to package an article (paragraph 0002). The article to be packaged may be medicine (paragraph 0108). The laminate comprises, in order, a base material layer, an adhesive layer, a barrier layer, an adhesive layer, a first sealant layer, and a second sealant layer (Figure 1 and paragraph 0018). The base material layer may be a combination of a paper and resin film (paragraph 0019), such as a paper and resin layer with an adhesive layer interposed between them wherein the paper layer is positioned towards the outside of the laminate and the resin layer is positioned towards the barrier layer (paragraphs 0110 - embodiment 9). The resin films may be biaxially oriented polyester or biaxially oriented polyamide having a preferred thickness of 6 to 30 mm (paragraph 0028). The adhesive layers may be solvent-type adhesives, aqueous adhesives, or adhesives that do not employ a solvent (i.e., reactive adhesive or hot-melt adhesive) (paragraphs 0023 and 0036). The thickness of the adhesive layers is 0.1 to 1.0 mm (paragraph 0042).
Hirose shows that paper adhered to biaxially oriented polyamide is suitable for use as the base layer of a laminate for packaging medicine. Therefore, it would have been obvious to one of ordinary skill in the art to use paper adhered to biaxially oriented polyamide at the thicknesses taught by Hirose as the support layer recited in the claims of copending Application No. 18/643,543 since the courts have held the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination.
Additionally, it would have been obvious to use the adhesives of Hirose as the lamination layers adhering the layers of laminate together since Hirose shows that they are known materials for this purpose and the courts have held the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination.
Regarding claim 3, the manner in which the biaxially oriented polyamide layer is formed represents a product-by-process type limitation. When the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claim in a product-by-process claim, the burden is on the applicant to present evidence from which the examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. In this case, one of ordinary skill in the art would expect biaxially oriented polyamide layers to have the same properties regardless of the manner in which they are made since the resulting material is a polyamide that has been biaxially oriented.
Regarding claim 13, in the absence of a showing of criticality or unexpected results, it would have required no more than routine experimentation and ordinary skill to determine a suitable thickness for the paper base material. Moreover, since the paper base material is employed in the same manner and for the same purpose as the paper layer of claim 13 (i.e., a base layer of a packaging laminate), one of ordinary skill in the art would expect routine experimentation to result in a paper layer satisfying the limitations of claim 13.
Regarding claim 14, while Hirose is silent regarding the coating weight of the adhesive layers, there is an explicit teaching that the adhesive layers are applied at a thickness of 0.1 to 1 mm (paragraph 0042) - a thickness that would be expected to satisfy the limitations of claim 14. In the event that adhesive layers of 0.1 to 1 mm do not inherently satisfy the limitations of claim 14 and in the absence of a showing of criticality or unexpected results, it would have required no more than routine experimentation and ordinary skill to determine a suitable coating weight adhesive layer. Since the adhesive layer of Hirose is employed in the same manner and for the same purpose as the adhesive layers of claim 14 (i.e., a laminating adhesive of a packaging laminate), one of ordinary skill in the art would expect routine experimentation to result in adhesive layers satisfying the limitations of claim 14.
This is a provisional nonstatutory double patenting rejection.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-15 of copending Application No. 18/643,543 in view of Hirose (US 2020/0001579), as applied to claim 1 above, and further in view of Fogtmann (US 2022/0274392).
Claims 1 and 10-15 of copending Application No. 18/643,543 taken in view of Hirose recite all the limitations of claim 7, as outlined above, except for the use of a polyamide contact layer as opposed to a layer comprising a cyclic olefin copolymer or ethylene vinyl alcohol.
Fogtmann (US 2022/0274392) is directed to a laminate film used as packaging for drugs (paragraph 0002). The contact layer of the laminate film may be a polyamide, a cyclic olefin copolymer, or ethylene vinyl alcohol (paragraph 0045).
That is, Fogtmann shows that polyamide, a cyclic olefin copolymer, and ethylene vinyl alcohol are known in the art as functionally equivalent materials for contact layers of a laminate used in packaging drugs. Therefore, because these materials were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a cyclic olefin copolymer or ethylene vinyl alcohol for the polyamide claimed in copending Application No. 18/643,543.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAMSEY E ZACHARIA whose telephone number is (571)272-1518. The best time to reach the examiner is weekday mornings, Eastern time.
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/RAMSEY ZACHARIA/Primary Examiner, Art Unit 1787
